Description

Introduce Western biotech firms and the regulatory communities, the Drug Regulators, to the Chinese Biopharmaceutical Industries. Learn each othersâ€™ capabilities and capacities for product development and manufacturing. Learn the technical, scientific, medical and legal aspects of the processes associated with research and development, drug discovery; and developing and bringing biopharmaceuticals and pharmaceuticals to market in China and in the West. These areas include standards, trade practices, case studies, and regulation, as well as distribution/networking, market development internal to and external from China for Chinese and non-Chinese product, bulk product, and an exploration of the benefits of stable supplies of APIs. Of particular emphasis will be papers and presentations from professionals who are in the regulatory agencies of each producing country or who are very familiar with the regulatory process and procedures from each region such as the US and the Americas, the EU, Middle East, Pacific Rim and Asian countries. Contributions of papers and posters from each area are solicited.
This ICBPS II will bring the international pharmaceutical, biopharmaceutical and regulatory communities together to further dialog and cooperation. Goals and objectives include learning each others capabilities for product development and manufacturing; learning the technical, scientific, medical and legal aspects of research and development, drug discovery, and bringing biopharmaceuticals and pharmaceuticals to market in China and the West. These areas include standards and trade practices, case studies and regulation, as well as distribution and networking, market development in China and the West for Chinese and non-Chinese product, and an exploration of the benefits of having stable supplies of Active Pharmaceutical Ingredient (API).

This ICBPS II effort follows the very successful ICBPS I which was held in Beijing in December 2006. As one member of the Western diplomatic community noted about ICBPS I, "A World Class event". Some of the papers at ICBPS I included:

Partnerships from applied science to commercialization
Anti-body based biopharmaceuticals in China
Conjugate vaccine development in China
The third revision of the Chinese patent law
Licensing of medical products requires using alternate approaches on efficacy demonstration when traditional human clinical trials are not possible
The clinical trial for a new drug in China
A novel polyepitope Malaria vaccine randomly constructed with epitope shuffling
Correlation of disulfide bond conformation to hormonal activity of oxytocin
The biopharmaceutical market in Brazil
An overview of the drug sector within the Saudi Food and Drug Authority with emphasis on biologicals
Key factors in the growing European biotechnology sector

Call for papers: The primary theme for ICBPS II is Vaccines to include therapeutic proteins; and, sub topic areas across the spectrum of related areas.

This is a science and industry meeting for professionals to exchange ideas for developing, testing, and manufacturing vaccines and biotherapeutics in both China and Western countries. This exchange will be between government, industry, science, medical, legal and business professionals. This should include considerations in standardizing materials, production and testing procedures, regulations and registration requirements.

Chinese and Western industries have much to gain from each other beyond scientific exchange: China has capabilities and capacities to produce both intermediates and final drug chemicals and biologicals and Western companies have knowledge and ability to test and produce drugs and biologicals according to GLP/GMP standards. For industry - how do we ramp-up in an emergency, how do we keep the pipelines full? What pre-planning is required? How do we establish a presence to any level in China â€“ now. The ICBPS offers the opportunity to meet fellow professionals from China and other countries and to have them understand your concerns and requirements and for them to be able to do the same with you. The one on one personal contact really works in the ICBPS relaxed, shirt sleeved, professional environment.

Major Topic Areas

Vaccines and Therapeutic Proteins
Therapeutic vaccines for HIV, TB, diabetes, allergies, serious infectious and non-infectious bacterial and viral diseases; pandemic preparedness for emerging infections such as H5N1 and the possibilities of therapeutics for radiation poisoning treatment, example â€œHollis-Edenâ€™s drug candidate NEUMUNE (HE2100)â€ and others coming on line
Regulations and Regulatory Standardization for therapeutic as well as regular vaccines; and, Registration such as WHO requirements and WHO certification
New type vaccines, current R&D, preventatives; liability issues
Biopharmaceuticals, including vaccines, antibodies and broad spectrum immunomodulators as therapeutic agents. The focus is on new approaches/treatments for old/emerging diseases.
Transitioning from science to products; worldwide R&D, test, and evaluation; new product licensing and compliance, registration and regulation and standardization between countries and between organizations.
Bioresponsibility as a consideration when vaccine development and/or testing, requires work with live agent. This includes: Biosecurity, Biocontainement (even if virulence is not known), Bioethics, QC/QA, and appropriate SOPâ€™s to improve pathogen handling and identification of BSL requirements
Sub Topic Areas

Therapeutic vaccines â€“ are there acceptable animal models?
Regulatory standards â€“ Should they be the same for therapeutic products as for prophylactic vaccines?
What advanced technology may be needed for manufacturers to ramp up more quickly in the event of pandemic disease?
H5N1 Pandemic â€“ Where do we stand as regards improved vaccines and manufacturing methods and new drugs for prevention and treatment?
Equipment: Adoption of new technologies and guidelines; Disposable equipment required, available or in development; equipment manufacturers and their concepts on how new equipment might be used?
Production: Importance of requirements and procedures for GMP, especially for bulk active pharmaceutical ingredients (APIs). Stability, storage and purity of APIs. How to design a biopharmaceutical plant to meet GMP requirements and why they are important.
How to navigate and understand the regulatory environments -- in different countries.
The role of IP protection and rights in the drug and biotherapeutics industry.
Note 1: Papers should cover any one or a combination of the listed topic areas as well as areas not listed. For "non-listed" areas, the author should show how the subject fits within the theme of the Symposium.
Note 2: Because of the importance of the subject area to all countries, the ICBPS will consider applicants who wish to attend without a paper.

Some individual areas within the baskets of topics above that are already mentioned include:

Therapeutic vaccines
Emergent diseases and treatment. Emergency response.
Collaboration in research & biopharmaceutical production
Safety and evaluation of biopharmaceutical product
Diagnostic procedures and the contribution of biopharmaceuticals as reagents for diagnostic procedures
Biosafety and biosecurity
Methicillin-resistant Staphylococcus aureus (MRSA) and other drug resistance. What can be done?

Venue

Additional Information

Individuals may send their registration payment by 07 October 2008 to ASA/ICBPS. Payment may be by Visa, Master Card, American Express or check or electronic transfer. The special ASA-ICBPS bank account numbers for bank transfer will be supplied upon request.
Registration Fees: Before 08 October = US $975.00;
After 07 October = US $1075.00
â€¢â€¢ Registration fee includes local transportation, most meals including lunches on each day of the Technical Symposium (8,9,10 December); Welcome reception, Symposium dinner and special events as arranged by the Hosts, all coffee breaks, conference materials, tour with industry and Great Wall tour.
Hotel Fees: Hotel Crowne Plaza: Single (S); Double (D)
Superior Room (most are Twin beds) â€“ RMB 1250.00
Delux Room (most are King bed) â€“ RMB 1450.00
Executive Superior Room â€“ RMB 1630.00
Executive Deluxe room â€“ RMB 1750.00
Business suite â€“to be supplied soon
Rates include 15% hotel service charge and breakfasts for 1 or 2 persons. There are no added charges for the second person (accompanied person) in a room. The US Dollar converts to about 7 RMB Chinese.
Hotels require one night booking fee. This can be held by credit card to ASA/ICBPS who will then guarantee Hotel Booking Fee to the Travel Agency selected by the Chinese ICBPS Organizing Committee to assist with all travel arrangements within China for this meeting.